ISO 13485 certification in Brazil

ISO 13485 certification in Brazil at a glance

In Brazil, a medical device maker faces two parallel conversations: with Anvisa about registration and good manufacturing practice certificates, and with auditors about the quality system. Anvisa, created by Law No. 9,782 of 1999, publishes lists of certified companies and carries a MDSAP topic on its site, while ISO 13485 certification is issued by an accredited certification body and does not replace either. Cgcre, Inmetro's accreditation coordination, is a Global ACI Full Member with ISO 13485 among its recognised scopes. Contract manufacturers and component suppliers meet the standard through their customers' supplier controls, so the same system serves several customers. Sterling's New York office supports gap analysis, design controls, risk management, validation, supplier controls and internal audits, with Effivity and Sterling Academy included with the engagement.

Who needs ISO 13485 in Brazil, and what happens without it

In Brazil the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.

• Medical device manufacturers selling in BrazilAnvisa's good manufacturing practice certificates are separate from, but connected to, the quality system a device maker must run.
• Contract manufacturers and component suppliers to device makersDevice makers audit suppliers' quality systems, and ISO 13485 is the language they use.
• Exporters of devices to regulated marketsForeign regulators and notified bodies expect a device quality system.
• In vitro diagnostic and software-as-a-medical-device companiesTheir quality systems are audited under the same standard.
• Distributors and service companies in the device chainImporters and servicers are audited by manufacturers.

ISO 13485 requirements in Brazil

Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.

In Brazil these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →

• ISO 13485 requirements, clause by clause in plain language

How to get ISO 13485 certified in Brazil

One team from the New York office carries the work from scoping to certificate. Clients across Brazil are served from Sterling's New York office, on-site where the work needs it and remotely otherwise.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO 13485 and the Brazilian requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
5. Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• The ISO 13485 certification process, step by step
• ISO 13485 internal audit

How long does ISO 13485 certification take in Brazil?

There is no standard duration: it depends on your scope and on how much of the system already runs. In Brazil these are the factors that set the timeline.

• Device class and regulatory markets targeted
• Design control, risk management and traceability maturity
• Supplier and subcontractor controls
• Certification body and regulator audit scheduling

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• Scope and timeline estimator

How much does ISO 13485 certification cost in Brazil?

The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In Brazil these factors move both.

• Device classes, sites and processes in scope
• Cleanroom, validation and traceability upgrades
• Certification body audit fees, quoted separately from consulting
• Regulatory submissions, handled outside the certificate

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 13485

ISO 13485 consultants and certification bodies in Brazil

Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in Brazil are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 13485 in Brazil: questions clients ask

More on ISO 13485 for Brazilian organisations

• ISO 13485: the complete guide
• Watch: How to implement ISO 13485
• ISO 13485 certification in Brazil and every other standard Sterling delivers there

Other standards Brazilian businesses ask Sterling for

Organisations in Brazil often combine ISO 13485 with one of these, under one management system where the scopes allow.

All 21 standards Sterling delivers in Brazil →